Evidence map›Paper›PMID 25684604›Full record

Trial reportDiabetes research and clinical practice2015

Liraglutide pharmacokinetics and dose-exposure response in Asian subjects with Type 2 diabetes from China, India and South Korea.

S H Ingwersen, K C Petri, N Tandon, K-H Yoon, L Chen, J Vora, W Yang

Registry-linked trialAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Diabetes research and clinical practice, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It reports registered trial NCT00614120. Cited by 9 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 1 pooled it
1.6field-weighted citation impact, top 16% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT00614120 phase3completed

Effect of Liraglutide or Glimepiride Added to Metformin on Glycaemic Control in Subjects With Type 2 Diabetes

Ran2008Enrolled929Registered outcomes8Posted comparisons3ConditionsDiabetes, Diabetes Mellitus, Type 2ArmsGlimepiride, liraglutide, Metformin, Placebo
PMID 23010561PMID 25504028PMID 21114607other papers from this trial
Open the trial in the graph
3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 1 synthesis or guideline pooled it, 14 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. Article
  5. Article
  6. Article
  7. Clinical Impact of Liraglutide as a Treatment of Obesity.Clinical pharmacology : advances and applications · 2021
    Review
  8. Review
  9. Observational
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors at 6 institutions in 5 countries.

S H IngwersenNovo Nordisk A/S, Søborg, Denmark. Electronic address: si@novonordisk.com.
K C PetriNovo Nordisk A/S, Søborg, Denmark.
N TandonAll India Institute of Medical Sciences, New Delhi, India.
K-H YoonCatholic Medical Center, The Catholic University of Korea, South Korea.
L ChenDepartment of Endocrinology, Wuhan Union Hospital, Wuhan, Hubei, China.
J VoraRoyal Liverpool University Hospitals, Liverpool, UK.
W YangDepartment of Endocrinology, China-Japan Friendship Hospital, Beijing, China.
All India Institute of Medical Sciences · INCatholic University of Korea · KRChina-Japan Friendship Hospital · CNNovo Nordisk (Denmark) · DKUniversity of Liverpool · GBWuhan Union Hospital · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsTo investigate the population pharmacokinetics and exposure-response relationship of liraglutide, a human glucagon-like peptide-1 (GLP-1) analogue, in Asian subjects with Type 2 diabetes mellitus.

methodsData were derived from a published 16-week, randomized, double-blind, double-dummy, active-controlled, parallel-group trial of liraglutide in China, India and South Korea. The analysis utilized 2061 pharmacokinetic (PK) samples from 605 subjects exposed to liraglutide 0.6, 1.2 or 1.8 mg once daily. Demographic factors (body weight, age, gender, country) of importance for liraglutide clearance were evaluated. An exploratory exposure-response analysis was conducted to investigate effects on glycated haemoglobin (HbA1c) and body weight.

resultsEstimated liraglutide exposure (area under the curve; AUC) appeared to increase proportionally with increasing liraglutide dose (0.6-1.8 mg). The covariate analysis confirmed previous findings in a global clinical trial. Body weight was a predictor of liraglutide exposure; compared to a reference subject of 67 kg, exposure was 32% lower for maximum (115 kg) and 54% higher for minimum (37 kg) observed body weights. Gender, age and country had no relevant effect on exposure. Exposure-response analysis supported the use of 1.2mg as maintenance dose with the option of individual dose escalation to 1.8 mg to optimize treatment outcomes.

conclusionsExposure appeared to increase proportionally with increasing liraglutide dose in Asian subjects with Type 2 diabetes mellitus. The only PK relevant predictor of exposure was body weight. The exposure-response relationships for HbA1c and body weight in Asian subjects were similar to observations in global populations.

Indexed as

Asian PeopleAdultAgedBlood GlucoseChinaDiabetes Mellitus, Type 2Double-Blind MethodFemaleGlycated HemoglobinHumansHypoglycemic AgentsIndiaLiraglutideMaleMiddle AgedRepublic of KoreaBlood GlucoseGlycated HemoglobinHypoglycemic AgentsLiraglutideExposure-responseLiraglutidePopulation pharmacokineticsType 2 diabetes

Identifiers

PMID25684604
OpenAlexW2171841658

What Socratic holds

Texttitle and abstract
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.